Blood Biomarkers and Gut Microbiota for Pancreatic Cancer Risk in Chronic Pancreatitis

NCT07762950 | Not Yet Recruiting

• 1 other identifier: CHEC2026-289
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn more about pancreatic cancer risk in people with chronic pancreatitis. Researchers will study blood markers and gut microorganisms, which are bacteria and other microbes living in the intestine. Researchers will compare healthy participants, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic cancer. The study will examine whether blood markers and gut microorganisms differ among these groups. It will also study how these features change over time and whether they may help identify people with chronic pancreatitis who are at higher risk of pancreatic cancer. Participants will provide blood and stool samples. Researchers will also collect health information, laboratory test results, and abdominal scan results. Participants with chronic pancreatitis will be followed about every 6 to 12 months. Participants with pancreatic cancer will also be followed according to their routine medical care schedule. Researchers will collect information about their treatment, disease changes, test results, scans, and survival status. Some participants with chronic pancreatitis or pancreatic cancer may be asked to provide additional blood or stool samples. Their permission will be confirmed before each additional sample is collected. Refusing an additional sample will not affect their routine medical care or continued follow-up in the study. No treatment will be assigned as part of this study. The findings may help improve future methods for assessing pancreatic cancer risk in people with chronic pancreatitis.

Conditions

Chronic Pancreatitis; Pancreatic Cancer

Keywords

Pancreatic Ductal Adenocarcinoma; Serum Biomarkers; Gut Microbiota; Microbial Translocation; Risk Stratification

Outcome Measures

Primary Outcomes (6)

• Serum or Plasma CXCL10 (IP-10) Concentration

  CXCL10 (IP-10) concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Serum or Plasma GLYR1 Concentration

  GLYR1 concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Serum or Plasma TGF-beta Concentration

  TGF-beta concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Serum or Plasma Artemin Concentration

  Artemin concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Gut Microbiota Shannon Diversity Index

  The Shannon diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Shannon diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Gut Microbiota Simpson Diversity Index

  The Simpson diversity index will be calculated from stool microbiome data generated using 16S ribosomal RNA gene sequencing and/or metagenomic sequencing. Baseline Simpson diversity will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will be evaluated in participants who provide repeat stool samples during follow-up.

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

Secondary Outcomes (2)

• Serum Lipopolysaccharide (LPS) Concentration

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

• Serum Soluble CD14 (sCD14) Concentration

  Baseline and approximately every 6 to 12 months thereafter, up to 30 months after enrollment

Study Arms (3)

Healthy Controls

Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts.

Chronic Pancreatitis

Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort. This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk.

Pancreatic Ductal Adenocarcinoma

Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.

You may qualify if:

• Adults aged 18 years or older.
• Able to understand the study procedures and provide written informed consent.
• Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
• Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
• Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
• Willing to provide blood samples and relevant clinical information.
• For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.

You may not qualify if:

• Unable or unwilling to provide written informed consent.
• Unable to provide required clinical information or biological samples.
• Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
• Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
• Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
• Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Sponsors & Collaborators

• Changhai Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples, including serum, plasma, whole blood, and peripheral blood mononuclear cells, and stool samples will be collected and retained. Blood samples will be used for serum biomarker measurements and selected immune-related and genetic analyses. Stool samples will be used for 16S ribosomal RNA gene sequencing, metagenomic sequencing, and related microbiome and metabolite analyses. All retained samples will be coded and stored for study-related analyses.

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Zhuan Liao, PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao, PhD

CONTACT

+86-21-31161001; zhuanleo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months after publication of the main study results and available for 5 years.
• Access Criteria: Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.